Vanderbilt-Ingram Cancer Center

The purpose of this study is to find out if the study drug BKM120 is safe and has a positive effect in people with NSCLC that has an activated PI3K pathway.

Criteria
 Inclusion Criteria:

 • Histologically confirmed NSCLC with activated PI3K pathway

 • Progressive disease after prior systemic antineoplastic treatment(s) for advanced NSCLC

 • Archival or fresh tumor biopsy must be available for profiling

 • Measurable and/or non-measurable disease as per RECIST 1.1 criteria

 • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

 • Adequate organ function as assessed by laboratory tests

 Exclusion Criteria:

 • Patient has received previous treatment with PI3K inhibitors

 • Patient with squamous NSCLC has received more than one line of chemotherapy treatment for metastatic disease; patient with non-squamous NSCLC has received more than two lines of systemic antineoplastic treatment for metastatic disease

 • Uncontrolled or symptomatic CNS metastases

 • Concurrent use of any other approved or investigational antineoplastic agent

 • Radiotherapy ≤ 28 days prior to starting study drug

 • Major surgery within 28 days prior to starting study drug

 • History of clinically significant cardiac dysfunction, mood disorders, or poorly controlled diabetes mellitus

 • Current treatment with medication that has a known risk to prolong the QT interval or inducing Torsades de Pointes

 • Impairment of gastrointestinal (GI) function

 • Chronic treatment with steroids or another immunosuppressive agent.

 • Concurrent severe and/or uncontrolled medical condition

 • Currently receiving Warfarin or another coumarin derivative

 • Known history of HIV infection

 • Sensory neuropathy with functional impairment (CTC grade 2 neuropathy, regardless of causality)

 • Pregnancy, lactation, or breastfeeding

 • Woman of child-bearing potential

 Other protocol-defined inclusion/exclusion criteria may apply